CLASS II ONGOING Device recall · Reported 8 Nov 2023 · FDA Enforcement Report

Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless recalled

Smiths Medical ASD is recalling Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, distributed in 18 states. The recall was initiated on 22 Aug 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #4125816, exp. 3/17/2026, UDI-DI 15021312005769.

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0205-2024
FDA event ID: 92996
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Ongoing
Recall initiated: 22 Aug 2023
FDA classified: 31 Oct 2023
Reported: 8 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

22 Aug 2023	Recall initiated by company
31 Oct 2023	Classified by FDA	+70 days
8 Nov 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

Where it was distributed

Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH, PA, SC, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada.

Arizona California Florida Hawaii Illinois Indiana Massachusetts Minnesota Missouri Mississippi North Carolina New Jersey Ohio Pennsylvania South Carolina Texas Virginia Washington

Questions about this recall

Why was it recalled?

The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).

Which lots are affected?

Lot #4125816, exp. 3/17/2026, UDI-DI 15021312005769.

Where was it sold?

Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH, PA, SC, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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